Women under-represented in heart drug trials

LONDON (Reuters) – Women are under-represented in clinical
trials of heart drugs, leaving doctors in the dark as to how
treatments may work differently in their bodies, scientists
said on Tuesday.

Hormones, body weight and other biochemical factors all
mean men and women often respond differently to
pharmaceuticals. Yet research on heart disease is skewed
heavily toward men.

This is mainly because cardiovascular conditions are
erroneously perceived as “male” diseases, according to Dr
Verena Stangl of the Charite Hospital, Humboldt-University
Berlin, Germany.

“Because too few women participate in heart disease trials
we are not sure whether they really benefit from some
therapeutic strategies that have shown clinical benefit in
trials conducted predominantly in men,” she said.

“So, we prescribe drugs to women adapted from
evidence-based data obtained from studies conducted mainly in
men and we do not really know whether we help or harm the
female patients.”

Stangl and colleagues reached their conclusions, which were
published in the European Heart Journal, after a lengthy review
of articles on female-specific aspects of drug therapy.

Her call for increasing the numbers of women in heart
trials was backed by a editorial in the journal, which is
published by the European Society of Cardiology.

Dr Silvia Priori, associate professor of cardiology at the
University of Pavia, Italy, said research showed that of 300
new drugs filed for approval in the United States between 1995
and 2000, only 163 included an analysis by gender.

Yet 11 of the drugs showed a difference in the way a
woman’s body dealt with the drugs compared with a man’s.

Already known gender differences include the fact that
women are twice as likely as men to develop a persistent cough
if given ACE inhibitors for high blood pressure.

And researchers say that aspirin, while proven to help
reduce the risk of heart attacks in men, is of a questionable
benefit as a primary preventive in women.